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A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

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ClinicalTrials.gov Identifier: NCT04944992
Recruitment Status : Completed
First Posted : June 30, 2021
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Drug: Efinopegdutide 20 mg/mL Drug: Semaglutide 1.34 mg/mL Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease
Actual Study Start Date : August 4, 2021
Actual Primary Completion Date : October 19, 2022
Actual Study Completion Date : October 19, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Efinopegdutide
Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.
 Drug: Efinopegdutide 20 mg/mL
Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg
Other Names:
  • MK-6024
  • HM12525A
  • JNJ-64565111
Active Comparator: Semaglutide
Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
 Drug: Semaglutide 1.34 mg/mL
Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Other Name: Ozempic®


Outcome Measures
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Primary Outcome Measures :
  1. Mean Relative Reduction from Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 weeks [ Time Frame: At Baseline and 24 weeks ]
    LFC will be measured with liver images taken by MRI-PDFF and analyzed by BICR. The mean relative reduction (%) from baseline in LFC after 24 weeks of treatment will be reported.

  2. Number of Participants Who Experience an Adverse Event [ Time Frame: Up to Approximately 28 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  3. Number of Participants Who Discontinue Study Intervention Due to an Adverse Event [ Time Frame: Up to approximately 24 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.


Secondary Outcome Measures :
  1. Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks [ Time Frame: At Baseline and 24 weeks ]
    LFC will be measured by liver images taken by MRI-PDFF and analyzed by BICR. The mean absolute reduction from baseline in LFC after 24 weeks of treatment will be reported.

  2. Mean Percent Change from Baseline in Body Weight After 24 weeks [ Time Frame: At Baseline and 24 Weeks ]
    Body weight (kg) will be measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks will be reported.

  3. Mean Change from Baseline in Total Cholesterol After 24 Weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in total cholesterol.

  4. Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in non-HDL-C.

  5. Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in HDL-C.

  6. Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in LDL-C.

  7. Mean Change from Baseline in Triglycerides (TG) After 24 Weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in triglycerides.

  8. Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks [ Time Frame: At Baseline and 24 Weeks ]
    Fasting blood samples will be collected at baseline and after 24 weeks of treatment to assess mean change in apoB.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver Fat Content (LFC) ≥10% as assessed by MRI-PDFF at time of screening.
  • Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening.
  • Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit.
  • No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an A1C ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention.
  • Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive).
  • Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive).

Exclusion Criteria:

  • History of T1DM, diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy.
  • Ongoing, inadequately controlled hypothyroidism or hyperthyroidism.
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.
  • Recent event (within 6 months prior to screening ) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack.
  • History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH).
  • Known history of cirrhosis.
  • History of acute or chronic pancreatitis.
  • History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality.
  • History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer.
  • Clinically active hematologic disorder.
  • Diagnosis of human immunodeficiency virus (HIV).
  • Surgery requiring general anesthesia within 3 months before screening visit.
  • History of organ transplantation, except for corneal transplant.
  • Active diabetic proliferative retinopathy or a history of maculopathy.
  • Untreated obstructive sleep apnea.
  • History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening.
  • History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening.
  • Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies.
  • Treatment with systemic corticosteroid medication within 3 months before screening.
  • Current treatment with anticoagulants (eg, warfarin, heparin).
  • Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination.
  • Previous or current history of significant alcohol consumption (average of 7 standard drinks per week in females or 14 standard drinks per week in males) for a period of more than 3 consecutive months in the 24 months before screening.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944992


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04944992    
Other Study ID Numbers: 6024-001
MK-6024-001 ( Other Identifier: Merck )
2020-005136-30 ( EudraCT Number )
First Posted: June 30, 2021    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases